BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION RAD

    MDR report key: 10815812 · Received November 10, 2020

    Report

    Report Number
    10815812
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 3, 2020
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC XOMED, INC. RAD 40 ROTATABLE FUSION BLADE WAS BROKEN PRIOR TO USE. A NEW DEVICE WAS OPENED. THE TIP OF THE DEVICE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282381 FUSION RAD NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC XOMED, INC. 1884006EM 0218356289

    Patients

    Seq Age Sex Outcome Treatment
    1 17155 DA